EffectiveNess of Low-dose Aspirin in Prevention of Cancer in the Stomach and Oesophagus (GastrointEstinal Cancer Prevention) - United Kingdom ("ENgAGE - UK"): Study to Evaluate the Risk of Cancer in the Stomach and Oesophagus Among New Users of Low-dose Aspirin Using the THIN Database in the UK

NCT ID: NCT03743883

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-30

Study Completion Date

2019-05-31

Brief Summary

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Researchers already did studies in low-dose Aspirin for the prevention of heart and blood vessels disease and for the prevention of cancer of the colorectum. In this study, they want to learn whether an effect for the prevention of oesophagus cancer and stomach cancer goes along with the use of low-dose ASA on patients taking this medicine for the prevention of heart and blood vessels disease compared to non-use. To find this out electronic medical records stored in primary care database in the UK, The Health Improvement Network (THIN), will be used.

Detailed Description

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Conditions

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Prevention of Oesophagus Cancer and Stomach Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Low-dose ASA cohort

A person is identified as newly exposed to low-dose ASA, he/she will become member of new user low-dose ASA cohort and that date will be the start date for outcome follow-up.

Acetylsalicylic Acid(BAYE4465, Aspirin )

Intervention Type DRUG

Administration according to clinical practice

Comparison unexposed cohort

When a member of new user low-dose ASA cohort is confirmed, one comparison member will be confirmed also from the source population not yet censored on that day (start date) and with the same distribution of matching factors (age, sex, time interval since entry date and number of PCP visits in the year prior to start date) of its low-dose ASA pair with the only difference of being free of ASA on start date.

No interventions assigned to this group

Interventions

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Acetylsalicylic Acid(BAYE4465, Aspirin )

Administration according to clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 40-89 years
* Enrolled with the PCP for at least 2 years
* To have a history of computerized prescriptions in THIN for at least 1 year prior to start date

Exclusion Criteria

* To be exposed to low-dose ASA before entering in the study
* Having a diagnosis of any cancer before entering in the study
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Multiple Locations, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://clinicaltrials.bayer.com

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Other Identifiers

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20326

Identifier Type: -

Identifier Source: org_study_id

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